BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1213845 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05424
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT THE FORCEPS WERE STUCK IN THE OPEN POSITION, AFTER ATTEMPTING TO TAKE THE BIOPSY SAMPLE - HENCE WHEN WITHDRAWING THE FORCEP, IT WOULD NOT COME OUT OF THE BIOPSY VALVE ON THE BRONCHOSCOPE. VALVE HAD TO BE REMOVED TO GET THE FORCEP OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515231 0011761129

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK